Aortic StenosisCOMP-ASNCT06136689
Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
An observational study of Aortic Stenosis and Aortic Valve Disease, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Aortic Valve Disease, Aortic Valve Calcification
- How many people
- 55 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jan 2022to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will involve patients undergoing surgical aortic valve replacement (SAVR) for different phenotypes of severe AS (high-flow high-gradient, classical low-flow low-gradient, and paradoxical low-flow low-gradient) or moderate AS with coexisting aortic aneurysm as part of Bentall procedure. Patients undergoing heart transplant will be considered control group without aortic valve stenosis.
Who may be able to join
- aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
- pre-surgical computed tomography angiography
- informed consent
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Silesia
Katowice
Radoslaw Gocol, MD, PhD
- Recruiting
Poznan University of Medical Sciences
Poznan
Anna Olasinska-Wisniewska, MD, PhD
Tomasz Urbanowicz, MD, PhD
About this study
The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Aortic Stenosis - High Flow, High Gradient | patients undergoing surgical aortic valve replacement for severe AS | |
| Severe Aortic Stenosis - classical Low Flow, Low Gradient | patients undergoing surgical aortic valve replacement for severe AS | |
| Severe Aortic Stenosis - paradoxical Low Flow, Low Gradient | patients undergoing surgical aortic valve replacement for severe AS | |
| Moderate Aortic Stenosis | patients undergoing aortic root replacement (Bentall procedure) | |
| Heart Transplant | patients undergoing orthotopic heart transplant for any reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic valve tissue composition measured from pre-procedural computed tomography angiography
Quantitative analysis of aortic valve composition will be based on pre-surgical planning CTA images using semi-automated software (Autoplaque version 2.5, Cedars-Sinai Medical Center, Los Angeles, CA, USA) for calcified, non-calcified and total tissue volumes.
Measured: up to 30-days before surgery
Aortic valve tissue composition measured from quantitative histology
Different stains will be used to characterize composition of excised aortic valves (hematoxylin and eosin, Movat Pentachrome, Van Gieson's trichrome, Congo Red, anti-CD68 antibody
Measured: immediately post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Cardiac Society
- Responsible party
- Principal investigator, Kajetan Grodecki, Medical University of Warsaw
- Investigators
- Zenon Huczek, MD,PhD, Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136689
- Sponsor's protocol ID
- 1WR/DAR15
- Acronym
- COMP-AS
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304.
PubMed 33247903
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06136689
- Acronym / sponsor ID
- COMP-AS / 1WR/DAR15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Polish Cardiac Society
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Severe Aortic Stenosis - High Flow, High Gradient | – | –patients undergoing surgical aortic valve replacement for severe AS |
| Severe Aortic Stenosis - classical Low Flow, Low Gradient | – | –patients undergoing surgical aortic valve replacement for severe AS |
| Severe Aortic Stenosis - paradoxical Low Flow, Low Gradient | – | –patients undergoing surgical aortic valve replacement for severe AS |
| Moderate Aortic Stenosis | – | –patients undergoing aortic root replacement (Bentall procedure) |
| Heart Transplant | – | –patients undergoing orthotopic heart transplant for any reason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve patients undergoing surgical aortic valve replacement (SAVR) for different phenotypes of severe AS (high-flow high-gradient, classical low-flow low-gradient, and paradoxical low-flow low-gradient) or moderate AS with coexisting aortic aneurysm as part of Bentall procedure. Patients undergoing heart transplant will be considered control group without aortic valve stenosis.
Key inclusion criteria (3 listed)
- aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
- pre-surgical computed tomography angiography
- informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aortic valve tissue composition measured from pre-procedural computed tomography angiography
Time frame: up to 30-days before surgery
Quantitative analysis of aortic valve composition will be based on pre-surgical planning CTA images using semi-automated software (Autoplaque version 2.5, Cedars-Sinai Medical Center, Los Angeles, CA, USA) for calcified, non-calcified and total tissue volumes.
Aortic valve tissue composition measured from quantitative histology
Time frame: immediately post-surgery
Different stains will be used to characterize composition of excised aortic valves (hematoxylin and eosin, Movat Pentachrome, Van Gieson's trichrome, Congo Red, anti-CD68 antibody
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 33247903Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zenon Huczek, MD,PhD study director
Medical University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Aortic Valve Disease, run by Medical University of Warsaw at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kajetan Grodecki, MD, PhD (0048 660675782, kajetan.grodecki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic valve tissue composition measured from pre-procedural computed tomography angiography (time frame: up to 30-days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.